A Study to Evaluate the Risk of Developing a Heart Condition Called Valvular Regurgitation in Patients With Acromegaly Treated With Either Lanreotide or Octreotide - Full Text View

Purpose

The aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide

Condition	Phase
Acromegaly	Phase 4


Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	A Multicentre Prospective Controlled Observer Blinded Cohort Study in Patients With Acromegaly to Evaluate the Risk of Cardiac Valvular Regurgitation in Patients Treated With Lanreotide Relative to Patients Treated With Octreotide

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Acromegaly

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 12 months

Secondary Outcome Measures:

Assessment of the risk of new or worsening valvular regurgitation in any valve by echocardiography at baseline & 6 months
Risk in each of the 4 valves at 6 & 12 months
Risk of significant regurgitation in each valve at 6 & 12 months
Prevalence of valvular regurgitation at baseline
Assessment of GH and IGF-1 levels at baseline, 6 months & 12 months


Estimated Enrollment:	200
Study Start Date:	May 2003

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient has a diagnosis of Acromegaly
Patient is being treated with lanreotide or octreotide in any dose form at the selection visit or is a de novo patient who is due to commence treatment within 2 weeks of baseline
Patient started treatment with either lanreotide or octreotide when both products were available on the market in their country
Patient must not change treatment form lanreotide to octreotide or vice versa for the duration of the study

Exclusion Criteria:

Patients with known significant valve abnormalities prior to treatment with either lanreotide or octreotide
Patients who have received treatment with a somatostatin analogue other than lanreotide or octreotide for more than 3 months
Patients who have received treatment with a GH antagonist for more than 3 months
Patients who have had heart valve replacement therapy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234520

Show 33 Study Locations

Sponsors and Collaborators

Ipsen

Investigators


Study Director:	France Catus, MD	Ipsen

More Information

Publications:

Colao A, Marek J, Goth MI, Caron P, Kuhn JM, Minuto FM, Weissman NJ. No greater incidence or worsening of cardiac valve regurgitation with somatostatin analog treatment of acromegaly. J Clin Endocrinol Metab. 2008 Jun;93(6):2243-8. doi: 10.1210/jc.2007-2199. Epub 2008 Apr 1.


ClinicalTrials.gov Identifier:	NCT00234520 History of Changes
Other Study ID Numbers:	2-47-52030-721
Study First Received:	October 5, 2005
Last Updated:	June 26, 2008
Health Authority:	United States: Food and Drug Administration Belgium: Federal Agency for Medicines and Health Products, FAMHP Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Hungary: National Institute of Pharmacy Italy: Ministry of Health Spain: Ministry of Health Sweden: Medical Products Agency Poland: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:


Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases	Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

ClinicalTrials.gov processed this record on February 27, 2015